The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults
2022年3月14日 更新者：Brad Manor、Hebrew SeniorLife
Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls
The tDCS & Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
研究概览
详细说明
The ability to stand and walk safely, especially while performing additional cognitive tasks like talking, reading or decision making, is critical to the preservation of functional independence into old age.
Such "dual tasking" often impairs balance, even in healthy older adults and those with greater dual task "costs" are more likely to suffer future falls.
Transcranial direct current stimulation (tDCS) is a safe, noninvasive and inexpensive means of modulating activity across cortical networks.
A single, 20-minute session of tDCS facilitates brain activity for up to 24 hours.
Through Dr. Manor's previous research in healthy older adults, he has discovered that just 20 minutes of tDCS targeting the left dorsolateral prefrontal cortex (dlPFC)-a region involved in both cognitive and motor function-immediately reduces the dual task costs to balance when standing and walking, and improves performance in the timed up-and-go (TUG) test of mobility.
However, there are several brain networks with known involvement in balance control and dual tasking, and the optimal brain region to target to improve dual task capacity has not been established.
The proposed study will be a double-blinded, sham-controlled study in which older adults both with and without a history of falling undergo dual task assessments immediately before and after single, 20-minute sessions of tDCS designed to target several different brain regions with known involvement in dual tasking and the maintenance of balance.
研究类型
介入性
注册 (实际的)
61
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
"Faller" group
- Aged 65 years and older
- Able to read, write and communicate in English
- Self-report of 2 or more falls within the past 6 months
"Non-Faller" Group
- Aged 65 years and older
- Able to read, write, and communicate in English
- Self-report of 1 or no (zero) falls within the past 6 months
Exclusion Criteria:
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
- Montreal Cognitive Assessment score <18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active dermatological condition, such as eczema, on the scalp (see appendix for standardized tDCS screening questionnaire).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：Sham Stimulation
The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation.
The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA).
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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实验性的：M1 Stimulation
The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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实验性的：DLPFC Stimulation
The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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实验性的：M1+DLPFC Stimulation
The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA.
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There will be three different tDCS targets as well as a sham stimulation condition.
The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dual task cost to standing postural sway speed
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Dual task cost to gait speed when walking
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dual task cost to postural sway area
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to standing postural sway area will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task.
The dual task cost will be calculated as the percent change in postural sway area from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Dual task cost to gait variability when walking
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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The dual task cost to gait variability when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
The dual task cost will be calculated as the percent change in gait variability from single- to dual-task conditions.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway speed will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway area
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task postural sway area will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed variability when walking
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait variability when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed when walking
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Single task gait speed when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Mobility
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Mobility will be assessed using the Timed Up-and-Go test in which the amount of time it takes for the participant to stand up from a chair, walk three meters, turn around a cone, walk back, and sit down is recorded.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Executive function will be assessed using the Stroop test.
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS.
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Attention
大体时间：This outcome will be assessed immediately before and after each 20-minute session of tDCS
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Attention will be assessed using the Visual Search and Attention Test (VSAT).
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This outcome will be assessed immediately before and after each 20-minute session of tDCS
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Brad Manor、Institute for Aging Research, Hebrew SeniorLife
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月26日
初级完成 (实际的)
2019年11月26日
研究完成 (实际的)
2021年5月26日
研究注册日期
首次提交
2017年6月15日
首先提交符合 QC 标准的
2017年6月15日
首次发布 (实际的)
2017年6月19日
研究记录更新
最后更新发布 (实际的)
2022年3月15日
上次提交的符合 QC 标准的更新
2022年3月14日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.